Scar PreventionPhase 2NCT00811577

A Phase 2a Study to Evaluate the Safety and Efficacy of AZX100 in Trocar Sites of Arthroscopic Shoulder Surgery Patients

A Phase 2 study testing AZX100 in people with Scar Prevention and Scar Reduction, run by Capstone Therapeutics at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to determine the safety of AZX100 Drug Product and to determine whether it was effective in preventing or reducing scars that were made from trocars following arthroscopic shoulder surgery. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Scar Prevention, Scar Reduction
What is being tested?: AZX100
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 5 sitesUnited States
Study dates: Jan 2009to Dec 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Scheduled for an arthroscopic shoulder surgery that will result in at least 3 trocar sites
Healthy male or non-pregnant female 18-75 years old
Non-diabetic
Body Mass Index 18-35
No clinically significant abnormal values on blood test
Non-smoker for previous 6 months

Who cannot join

History of acute or chronic disease
Cancer within previous 5 years, except for removed skin cancer
Hypersensitivity reaction
Allergy to general anesthesia, lidocaine, or epinephrine
Current skin disorder other than folliculitis or acne
On therapy with steroids

Show all 17Show fewer

On therapy with a drug that affects collagen synthesis
Positive for HIV or hepatitis
Positive urine test for nicotine
Positive blood test for anti-AZX100 antibodies
Participated in another clinical study within 60 days before enrollment
Gave blood within 7 days before dosing
Gave plasma within 3 days before dosing
Tattoo on the shoulder area
Applied any prescribed or over the counter agents to the shoulder within 14 days before dosing, or intend to use any scar improving product
Visited a tanning salon within 14 days before dosing
History of drug addiction or excessive use of alcohol

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Texas Orthopedics, Sports & Rehab Assoc.
Austin, Texas, 78759
Florida Research Associates
DeLand, Florida, 32720
Orthopaedics East, PA
Greenville, North Carolina, 27834
Atlas Orthopedics & Sports Medicine
Orlando, Florida, 32822
Lotus Clinical Research, Inc.
Pasadena, California, 91105

Other trials in United States

About this study

Official title: A Phase 2a Double Blind, Placebo Within-Patient Controlled, Multi-Center Dose Ranging Study to Evaluate the Safety and Preliminary Efficacy of AZX100 Drug Product in Trocar Sites of Arthroscopic Shoulder Surgery Patients

Conditions: Scar Prevention, Scar Reduction
Being tested: Placebo, AZX100
Keywords: AZX100, Patient and Observer Scar Assessment Scale, POSAS, Visual Analog Scale, VAS, Trocar, Scarring, Scar reduction, Scar prevention
Medical subject headings: Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Patients in the Placebo-only arm were dosed intradermally with placebo (saline) in three trocar sites on Day 9 (plus/minus 2 days) and Day 21 (plus/minus 2 days) after arthroscopic shoulder surgery. In the AZX100-placebo arm, 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.
AZX100Drug
AZX100 Drug Product 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.

Study groups in NCT00811577
Study group	Role	What they receive
AZX100-placebo	Experimental	Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive one low dose of AZX100 3 mg/linear cm, one high dose of AZX100 10 mg/linear cm, or placebo (saline). Receives: Drug: Placebo; Drug: AZX100
Placebo-only	Placebo comparator	Three trocar sites on each patient received one dose of placebo (saline). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores
Efficacy was based on the difference between mean POSAS scores of placebo and 3 mg AZX100, and placebo and 10 mg AZX100 12 months after shoulder surgery. Three trocar sites were randomized on each patient to receive AZX100 3 mg or AZX100 10 mg or placebo at 9 days and 21 days after shoulder surgery. PSAS results included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS results included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.
Measured: 12 months

Secondary outcomes (5)

Between-group Mean Differences in Visual Analog Scale Scores Rated by Independent Blinded Raters Using 3D Photography
Three trocar sites were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or saline placebo/cm at 9 days and 21 days after surgery. Twelve months after surgery, images of the trocar sites were longitudinally evaluated and rated using a standard 100 mm Visual Analog Scale (VAS) by two blinded independent dermatologists, with 0 being normal skin and 100 being the worst scar imaginable. Efficacy was based on the difference between VAS scores of placebo and 3 mg AZX100 and placebo and 10 mg AZX100 for each of the two raters separately. Data from both raters was not combined.
Measured: 12 months
Between-group Mean Differences in Objective Measures Via 3D Photography (Elevation, Length, Width)
Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. 3D digital photography of each trocar scar was used to calculate scar length, width, minimum elevation, and maximum elevation in millimeters (mm) at 12 months. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smooth skin surface. This was always a negative number. Negative values (closer to zero) were more desirable. The maximum elevation value was the highest point of the scar above the interpolated smooth skin surface. A smaller value was preferred.
Measured: 12 months
Between-group Mean Differences in Objective Measures Via 3D Photography (Volume)
Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm, or AZX100 10 mg/cm, or placebo/cm at 9 days and 21 days following shoulder surgery. 3D digital photography of each trocar scar was used to calculate positive volume, negative volume, and total volume in millimeters cubed (mm^3) at 12 months. Positive volume included the scar volume that was calculated to be above the interpolated smooth skin surface. A smaller value was preferred. Negative volume included the volume of the scar calculated to be below the interpolated smooth skin surface. It was always a negative number; negative values (closer to zero) were more desirable. Total volume was calculated as the sum of positive volume and the absolute value of negative volume. Smaller values were more desirable.
Measured: 12 months
Histological Evaluation of Collagen
Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. A skin punch biopsy was taken of each trocar site at 12 months. The specimens were blindly scored in duplicate by a dermal pathologist for dermal collagen fiber density, maturity and orientation, where 0% was completely normal and 100% was completely abnormal.
Measured: 12 months
Histological Evaluation of Number of Alpha Smooth Muscle Actin Cells
Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. A skin punch biopsy was taken of each trocar site at 12 months. For exploratory purposes, the specimens were blindly scored in duplicate by a dermal pathologist for the estimated number of alpha-smooth muscle actin (α-SMA) positive cells per high powered field. Values ranged from 0 to several hundred. The number of α-SMA cells was assessed for exploratory purposes; therefore, at the time of this report, it was not known whether it was better to have a low or high α-SMA score.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Dec 2010

First posted19 Dec 2008 (estimated)
Study startJan 2009
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Scar PreventionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00811577
Sponsor's protocol ID: OL-ASCAR-03
Status last verified: Sep 2012
First submitted: 18 Dec 2008
Last updated: 11 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a Double Blind, Placebo Within-Patient Controlled, Multi-Center Dose Ranging Study to Evaluate the Safety and Preliminary Efficacy of AZX100 Drug Product in Trocar Sites of Arthroscopic Shoulder Surgery Patients
ClinicalTrials.gov ID: NCT00811577
Acronym / sponsor ID: OL-ASCAR-03
Conditions: Scar Prevention, Scar Reduction
Keywords: AZX100, Patient and Observer Scar Assessment Scale, POSAS, Visual Analog Scale, VAS, Trocar, Scarring, Scar reduction
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Capstone TherapeuticsIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 19 Dec 2008 (estimated)
Results: Posted 11 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
AZX100-placebo	Experimental	Drug: Placebo, Drug: AZX100Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive one low dose of AZX100 3 mg/linear cm, one high dose of AZX100 10 mg/linear cm, or placebo (saline).
Placebo-only	Placebo comparator	Drug: PlaceboThree trocar sites on each patient received one dose of placebo (saline).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Scheduled for an arthroscopic shoulder surgery that will result in at least 3 trocar sites
Healthy male or non-pregnant female 18-75 years old
Non-diabetic
Body Mass Index 18-35
No clinically significant abnormal values on blood test

Key exclusion criteria (17 listed)

History of acute or chronic disease
Cancer within previous 5 years, except for removed skin cancer
Hypersensitivity reaction
Allergy to general anesthesia, lidocaine, or epinephrine
Current skin disorder other than folliculitis or acne

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPatients in the Placebo-only arm were dosed intradermally with placebo (saline) in three trocar sites on Day 9 (plus/minus 2 days) and Day 21 (plus/minus 2 days) after arthroscopic shoulder surgery. In the AZX100-placebo arm, 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.	Drug	AZX100-placebo, Placebo-only
AZX100AZX100 Drug Product 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.	Drug	AZX100-placebo

Primary outcome

Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores
Time frame: 12 months
Efficacy was based on the difference between mean POSAS scores of placebo and 3 mg AZX100, and placebo and 10 mg AZX100 12 months after shoulder surgery. Three trocar sites were randomized on each patient to receive AZX100 3 mg or AZX100 10 mg or placebo at 9 days and 21 days after shoulder surgery. PSAS results included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS results included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.

5 secondary outcomes

Between-group Mean Differences in Visual Analog Scale Scores Rated by Independent Blinded Raters Using 3D Photography
Time frame: 12 months
Between-group Mean Differences in Objective Measures Via 3D Photography (Elevation, Length, Width)
Time frame: 12 months
Between-group Mean Differences in Objective Measures Via 3D Photography (Volume)
Time frame: 12 months
Histological Evaluation of Collagen
Time frame: 12 months
Histological Evaluation of Number of Alpha Smooth Muscle Actin Cells
Time frame: 12 months

Results and safety

Results posted to the registry on 11 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZX100-Placebo Arm	126	116
Placebo-only Arm	24	23

Primary outcome: Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores

Time frame: 12 months. Mean (Standard Deviation). Unit: Units on a scale

Measure	PSAS Results for Placebo Trocar Scars n = 113	PSAS Results for 3 mg AZX100 Trocar Scars n = 113	PSAS Results for 10 mg AZX100 Trocar Scars n = 113	OSAS Results for Placebo Trocar Scars n = 113	OSAS Results for 3 mg AZX100 Trocar Scars n = 113	OSAS Results for 10 mg AZX100 Trocar Scars n = 113
Value	8.0 (4.1)	8.0 (4.7)	8.3 (5.0)	6.8 (2.7)	6.8 (2.5)	6.9 (2.5)

PSAS Results for Placebo Trocar Scars vs PSAS Results for 3 mg AZX100 Trocar Scars: p = 0.57, Wilcoxon (signed rank)
PSAS Results for Placebo Trocar Scars vs PSAS Results for 10 mg AZX100 Trocar Scars: p = 0.56, Wilcoxon (signed rank)
OSAS Results for Placebo Trocar Scars vs OSAS Results for 3 mg AZX100 Trocar Scars: p = 0.61, Wilcoxon (signed rank)

Population analysed: The efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including the patients receiving placebo-only). In the ITT sample for the POSAS outcomes, available sample sizes were 122 at Day 42 and 113 at Month 12 (including 4 subjects who withdrew from the study but were still followed for safety until Month 12).

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months). The adverse event collection period for the entire study lasted for a period of 24 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZX100-Placebo Arm	8 of 126 (6.3%)	125 of 126 (99.2%)	Not reported
Placebo-only Arm	2 of 24 (8.3%)	21 of 24 (87.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZX100 in people with Scar Prevention and Scar Reduction, run by Capstone Therapeutics at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00811577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2012.